Introduction: Therapeutic Apheresis Effects on Medications
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Requirements for Blood and Blood Components Intended for Transfusion Or for Further Manufacturing Use
Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use Office of Blood Research and Review CBER, FDA Ask the FDA Session – AABB Annual Meeting October 26, 2015 1 Outline • Overview – Historical Background – Intent of the Rule – Organization of the Rule • Selected Provisions – Relevant Transfusion-Transmitted Infection – Control of Bacterial Contamination of Platelets – Medical Supervision – Donor Acknowledgement – Alternative Procedures – Donor Eligibility • Implementation 2 GAO Oversight and FDA Concerns • Publish in the form of regulations the guidelines that FDA deems essential to ensure the safety of the blood supply • Concern about the delay in requiring testing for emerging infectious agents, e.g. HTLV • Concern about blood safety and the regulations being out-of-date • Concerns about donor safety 3 Intent of the Final Rule • To better assure the safety of the blood supply and to help protect donor health • To make donor eligibility and testing requirements more consistent with current practices and to provide flexibility with regard to emerging infectious diseases • To accommodate technological advances • To establish requirements for donor education, donor history, and donor testing 4 Organization of the Final Rule - 1 • A. General • B. Definitions (§§ 606.3, 610.39, 630.3, 640.125) • C. Standard Operating Procedures (§ 606.100) • D. Control of Bacterial Contamination of Platelets (§ 606.145) • E. Records (§ 606.160) • F. Test Requirements (§§ 610.40, 640.5, 640.71(a)) • G. Donor Deferral (§ 610.41) 5 Organization of the Final Rule - 2 • H. Purpose and Scope (§ 630.1) • I. Medical Supervision (§ 630.5) • J. General Donor Eligibility Requirements(§ 630.10) • K. Donor Eligibility Requirements Specific to Whole Blood, Red Blood Cells and Plasma Collected by Apheresis (§ 630.15) • L. -
27. Clinical Indications for Cryoprecipitate And
27. CLINICAL INDICATIONS FOR CRYOPRECIPITATE AND FIBRINOGEN CONCENTRATE Cryoprecipitate is indicated in the treatment of fibrinogen deficiency or dysfibrinogenaemia.1 Fibrinogen concentrate is licenced for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenaemia and hypofibrinogenaemia,2 and is currently funded under the National Blood Agreement. Key messages y Fibrinogen is an essential component of the coagulation system, due to its role in initial platelet aggregation and formation of a stable fibrin clot.3 y The decision to transfuse cryoprecipitate or fibrinogen concentrate to an individual patient should take into account the relative risks and benefits.3 y The routine use of cryoprecipitate or fibrinogen concentrate is not advised in medical or critically ill patients.2,4 y Cryoprecipitate or fibrinogen concentrate may be indicated in critical bleeding if fibrinogen levels are not maintained using FFP. In the setting of major obstetric haemorrhage, early administration of cryoprecipitate or fibrinogen concentrate may be necessary.3 Clinical implications y The routine use of cryoprecipitate or fibrinogen concentrate in medical or critically ill patients with coagulopathy is not advised. The underlying causes of coagulopathy should be identified; where transfusion is considered necessary, the risks and benefits should be considered for each patient. Specialist opinion is advised for the management of disseminated intravascular coagulopathy (MED-PP18, CC-PP7).2,4 y Cryoprecipitate or fibrinogen concentrate may be indicated in critical bleeding if fibrinogen levels are not maintained using FFP. In patients with critical bleeding requiring massive transfusion, suggested doses of blood components is 3-4g (CBMT-PP10)3 in adults or as per the local Massive Transfusion Protocol. -
Fluid Resuscitation Therapy for Hemorrhagic Shock
CLINICAL CARE Fluid Resuscitation Therapy for Hemorrhagic Shock Joseph R. Spaniol vides a review of the 4 types of shock, the 4 classes of Amanda R. Knight, BA hemorrhagic shock, and the latest research on resuscita- tive fluid. The 4 types of shock are categorized into dis- Jessica L. Zebley, MS, RN tributive, obstructive, cardiogenic, and hemorrhagic Dawn Anderson, MS, RN shock. Hemorrhagic shock has been categorized into 4 Janet D. Pierce, DSN, ARNP, CCRN classes, and based on these classes, appropriate treatment can be planned. Crystalloids, colloids, dopamine, and blood products are all considered resuscitative fluid treat- ment options. Each individual case requires various resus- ■ ABSTRACT citative actions with different fluids. Healthcare Hemorrhagic shock is a severe life-threatening emergency professionals who are knowledgeable of the information affecting all organ systems of the body by depriving tissue in this review would be better prepared for patients who of sufficient oxygen and nutrients by decreasing cardiac are admitted with hemorrhagic shock, thus providing output. This article is a short review of the different types optimal care. of shock, followed by information specifically referring to hemorrhagic shock. The American College of Surgeons ■ DISTRIBUTIVE SHOCK categorized shock into 4 classes: (1) distributive; (2) Distributive shock is composed of 3 separate categories obstructive; (3) cardiogenic; and (4) hemorrhagic. based on their clinical outcome. Distributive shock can be Similarly, the classes of hemorrhagic shock are grouped categorized into (1) septic; (2) anaphylactic; and (3) neu- by signs and symptoms, amount of blood loss, and the rogenic shock. type of fluid replacement. This updated review is helpful to trauma nurses in understanding the various clinical Septic shock aspects of shock and the current recommendations for In accordance with the American College of Chest fluid resuscitation therapy following hemorrhagic shock. -
Changes to the Technical Manual, 18Th Edition Monday, November 17, 2014 12:00 P.M
Changes to the Technical Manual, 18th Edition Monday, November 17, 2014 12:00 p.m. – 1:30 p.m. (ET) / 5:00p.m. – 6:30 p.m. (GMT) When this file is opened, Acrobat Reader will, by default, display the slides including the Acrobat reader controls. To return to full screen mode, hit Ctrl-L on your computer keyboard or use your mouse to click View>Full Screen on the menu bar of the Acrobat Reader program. To take the slides out of full screen mode and display the Acrobat Reader controls, simply hit the Esc key on your computer keyboard. To advance slides during the program, use the Enter, Page Down, down arrow or right arrow on your computer keyboard. To back up slides during the program, use the Page Up, up arrow of left arrow on your computer keyboard. Please remember to logon to the Live Learning Center using your email address and password to complete an evaluation of the program and speakers. At this time, advance to the next slide and wait for the audioconference to begin. A 2014 Audioconference presented to you by AABB The AABB Technical Manual 18th Edition What’s new? www.aabb.org Technical Manual by the Numbers • 1953 =year of first edition • 69 = number of authors/editors this edition • 370,378 = word count • 96 = number of methods • 60 = number of countries where TM is used www.aabb.org It’s a Process www.aabb.org Overview of Changes Major • Molecular testing • Patient blood management • Cellular therapy • Methods Minor • Throughout www.aabb.org 1: Quality Systems 2: Facilities and Safety • These 2 chapters are comprehensive discussions -
Blood Product Modifications: Leukofiltration, Irradiation and Washing
Blood Product Modifications: Leukofiltration, Irradiation and Washing 1. Leukocyte Reduction Definitions and Standards: o Process also known as leukoreduction, or leukofiltration o Applicable AABB Standards, 25th ed. Leukocyte-reduced RBCs At least 85% of original RBCs < 5 x 106 WBCs in 95% of units tested . Leukocyte-reduced Platelet Concentrates: At least 5.5 x 1010 platelets in 75% of units tested < 8.3 x 105 WBCs in 95% of units tested pH≥6.2 in at least 90% of units tested . Leukocyte-reduced Apheresis Platelets: At least 3.0 x 1011 platelets in 90% of units tested < 5.0 x 106 WBCs 95% of units tested pH≥6.2 in at least 90% of units tested Methods o Filter: “Fourth-generation” filters remove 99.99% WBCs o Apheresis methods: most apheresis machines have built-in leukoreduction mechanisms o Less efficient methods of reducing WBC content . Washing, deglycerolizing after thawing a frozen unit, centrifugation . These methods do not meet requirement of < 5.0 x 106 WBCs per unit of RBCs/apheresis platelets. Types of leukofiltration/leukoreduction o “Pre-storage” . Done within 24 hours of collection . May use inline filters at time of collection (apheresis) or post collection o “Pre-transfusion” leukoreduction/bedside leukoreduction . Done prior to transfusion . “Bedside” leukoreduction uses gravity-based filters at time of transfusion. Least desirable given variability in practice and absence of proficiency . Alternatively performed by transfusion service prior to issuing Benefits of leukoreduction o Prevention of alloimmunization to donor HLA antigens . Anti-HLA can mediate graft rejection and immune mediated destruction of platelets o Leukoreduced products are indicated for transplant recipients or patients who are likely platelet transfusion dependent o Prevention of febrile non-hemolytic transfusion reactions (FNHTR) . -
Intraoperative Fluid Therapy and Pulmonary Complications
■ Feature Article Intraoperative Fluid Therapy and Pulmonary Complications KRZYSZTOF SIEMIONOW, MD; JACEK CYWINSKI, MD; KRZYSZTOF KUSZA, MD, PHD; ISADOR LIEBERMAN, MD, MBA, FRCSC abstract Full article available online at ORTHOSuperSite.com. Search: 20120123-06 The purpose of this study was to evaluate the effects of intraoperative fl uid therapy on length of hospital stay and pulmonary complications in patients undergoing spine surgery. A total of 1307 patients were analyzed. Sixteen pulmonary complications were observed. Patients with a higher volume of administered crystalloids, colloids, and total intravenous fl uids were more likely to have postoperative respiratory com- plications: the odds of postoperative respiratory complications increased by 30% with an increase of 1000 mL of crystalloid administered. The best cutoff point for total fl uids was 4165 mL, with a sensitivity of 0.8125 and specifi city of 0.7171, for postoperative pulmonary complications. A direct correlation existed between fl uids and length of stay: patients who received Ͼ4165 mL of total fl uids had an average length of stay of 3.88Ϯ4.66 days vs 2.3Ϯ3.9 days for patients who received Ͻ4165 mL of total fl uids (PϽ.0001). This study should be considered as hypothesis-generating to design a prospective trial comparing high vs low intraoperative fl uid regiments for patients undergoing spine surgery. Dr Siemionow is from the Department of Orthopaedic Surgery, University of Illinois, Chicago, Illinois; Dr Cywinski is from the Department of Anesthesia, Cleveland Clinic, Cleveland, Ohio; Dr Kusza is from the Department of Anesthesia, Centrum Medyczne Bydgoszcz, Bydgoszcz, Poland; and Dr Lieberman is from Texas Back Institute, Plano, Texas. -
Guidance for the Provision of Intraoperative Cell Salvage
Enter Organisation details here GUIDANCE FOR THE PROVISION OF INTRAOPERATIVE CELL SALVAGE Guidance Guidance forfor Australian Australian Health Health Providers Providers MARCH> MARCH 2014 2014 Guidance for the provision of Intraoperative Cell Salvage Page 0 Ref No: Enter Organisation Ref AUS ICS Version No: 1 March 2014 Enter Organisation details here With the exception of any logos and registered trademarks, and where otherwise noted, all material presented in this document is provided under a Creative Commons Attribution 3.0 Australia (http://creativecommons.org/ licenses/by/3.0/au/) licence. The details of the relevant licence conditions are available on the Creative Commons website (accessible using the links provided) as is the full legal code for the CC BY 3.0 AU license (http://creativecommons.org/licenses/by/3.0/au/legalcode). The content obtained from this document or derivative of this work must be attributed as the Guidance for the provision of Intraoperative Cell Salvage. © National Blood Authority, 2014. ISBN 978-0-9873687-3-7 This report is available online at: www.blood.gov.au For more information: Patient Blood Management National Blood Authority Locked Bag 8430 Canberra ACT 2601 Phone: 13000 BLOOD (13 000 25663) Email: [email protected] www.blood.gov.au Guidance for the provision of Intraoperative Cell Salvage Page 1 Ref No: Enter Organisation Ref AUS ICS Version No: 1 March 2014 Enter Organisation details here Guidance for the provision of Intraoperative Cell Salvage Author: Policy ratified by: Responsible Officer: Signature Date Insert Date Classification Clinical Date Issued Area Applicable Review Date Ref No: Version No: Disclaimer When using this document please ensure that the version you are using is the current, in date version by checking on your Organisation’s database for any new versions. -
Update on Volume Resuscitation Hypovolemia and Hemorrhage Distribution of Body Fluids Hemorrhage and Hypovolemia
11/7/2015 HYPOVOLEMIA AND HEMORRHAGE • HUMAN CIRCULATORY SYSTEM OPERATES UPDATE ON VOLUME WITH A SMALL VOLUME AND A VERY EFFICIENT VOLUME RESPONSIVE PUMP. RESUSCITATION • HOWEVER THIS PUMP FAILS QUICKLY WITH VOLUME LOSS AND IT CAN BE FATAL WITH JUST 35 TO 40% LOSS OF BLOOD VOLUME. HEMORRHAGE AND DISTRIBUTION OF BODY FLUIDS HYPOVOLEMIA • TOTAL BODY FLUID ACCOUNTS FOR 60% OF LEAN BODY WT IN MALES AND 50% IN FEMALES. • BLOOD REPRESENTS ONLY 11-12 % OF TOTAL BODY FLUID. CLINICAL MANIFESTATIONS OF HYPOVOLEMIA • SUPINE TACHYCARDIA PR >100 BPM • SUPINE HYPOTENSION <95 MMHG • POSTURAL PULSE INCREMENT: INCREASE IN PR >30 BPM • POSTURAL HYPOTENSION: DECREASE IN SBP >20 MMHG • POSTURAL CHANGES ARE UNCOMMON WHEN BLOOD LOSS IS <630 ML. 1 11/7/2015 INFLUENCE OF ACUTE HEMORRHAGE AND FLUID RESUSCITATION ON BLOOD VOLUME AND HCT • COMPARED TO OTHERS, POSTURAL PULSE INCREMENT IS A SENSITIVE AND SPECIFIC MARKER OF ACUTE BLOOD LOSS. • CHANGES IN HEMATOCRIT SHOWS POOR CORRELATION WITH BLOOD VOL DEFICITS AS WITH ACUTE BLOOD LOSS THERE IS A PROPORTIONAL LOSS OF PLASMA AND ERYTHROCYTES. MARKERS FOR VOLUME CHEMICAL MARKERS OF RESUSCITATION HYPOVOLEMIA • CVP AND PCWP USED BUT EXPERIMENTAL STUDIES HAVE SHOWN A POOR CORRELATION BETWEEN CARDIAC FILLING PRESSURES AND VENTRICULAR EDV OR CIRCULATING BLOOD VOLUME. Classification System for Acute Blood Loss • MORTALITY RATE IN CRITICALLY ILL PATIENTS Class I: Loss of <15% Blood volume IS NOT ONLY RELATED TO THE INITIAL Compensated by transcapillary refill volume LACTATE LEVEL BUT ALSO THE RATE OF Resuscitation not necessary DECLINE IN LACTATE LEVELS AFTER THE TREATMENT IS INITIATED ( LACTATE CLEARANCE ). Class II: Loss of 15-30% blood volume Compensated by systemic vasoconstriction 2 11/7/2015 Classification System for Acute Blood FLUID CHALLENGES Loss Cont. -
Fluid Resuscitation for Hemorrhagic Shock in Tactical Combat Casualty Care TCCC Guidelines Change 14-01 – 2 June 2014
Fluid Resuscitation for Hemorrhagic Shock in Tactical Combat Casualty Care TCCC Guidelines Change 14-01 – 2 June 2014 Frank K. Butler, MD; John B. Holcomb, MD; Martin A. Schreiber, MD; Russ S. Kotwal, MD; Donald A. Jenkins, MD; Howard R. Champion, MD, FACS, FRCS; F. Bowling; Andrew P. Cap, MD; Joseph J. Dubose, MD; Warren C. Dorlac, MD; Gina R. Dorlac, MD; Norman E. McSwain, MD, FACS; Jeffrey W. Timby, MD; Lorne H. Blackbourne, MD; Zsolt T. Stockinger, MD; Geir Strandenes, MD; Richard B, Weiskopf, MD; Kirby R. Gross, MD; Jeffrey A. Bailey, MD ABSTRACT This report reviews the recent literature on fluid resusci- to hypotensive resuscitation, the use of DP, adverse ef- tation from hemorrhagic shock and considers the appli- fects resulting from the administration of both crystal- cability of this evidence for use in resuscitation of combat loids and colloids, prehospital resuscitation with thawed casualties in the prehospital Tactical Combat Casualty plasma and red blood cells (RBCs), resuscitation from Care (TCCC) environment. A number of changes to the combined hemorrhagic shock and traumatic brain in- TCCC Guidelines are incorporated: (1) dried plasma jury (TBI), balanced blood component therapy in DCR, (DP) is added as an option when other blood compo- the benefits of fresh whole blood (FWB) use, and re- nents or whole blood are not available; (2) the wording suscitation from hemorrhagic shock in animal models is clarified to emphasize that Hextend is a less desir- where the hemorrhage is definitively controlled prior to able option than whole blood, blood components, or resuscitation. DP and should be used only when these preferred op- tions are not available; (3) the use of blood products Additionally, recently published studies describe an in certain Tactical Field Care (TFC) settings where this increased use of blood products by coalition forces in option might be feasible (ships, mounted patrols) is dis- Afghanistan during Tactical Evacuation (TACEVAC) cussed; (4) 1:1:1 damage control resuscitation (DCR) Care and even in TFC. -
View Table of Contents
Table of Contents Preface. xv About the Authors . xvii Section 1: ABO: The Birth of Blood Groups 1. Blood Groups—From Then ’Til Now . .1 Discovery . .1 Response and Reconsideration . .2 Beyond ABO . .4 M, N, and P . .5 Rh . .6 The Antiglobulin Test . .7 The Plot Thickens . .7 References . .8 2. Karl Landsteiner, Father of Blood Groups . .9 Beginnings . .9 Medical School . .11 The Young Researcher . .13 Priority Issues . .16 Decastello and Sturli: Another Blood Group . .18 Other Directions . .19 Life in Vienna . .21 References . .23 3. ABO Grows Up . .27 Transfusion History, 1600 to 1920 . .27 The Blood Groups Gain Attention . .29 Transfusion in World War I . .37 Advances in ABO Blood Group Serology . .39 References . .47 4. Genetics, Eugenics, and Blood Groups . .51 Heredity, 1900 . .52 The Rise of Genetics . .52 Genes and Blood Groups . .53 viii BLOODY BRILLIANT! Genes and Populations . 59 References . 62 5. Karl Landsteiner in New York . 65 At “The Rockefeller” . 65 Landsteiner Returns to the Blood Groups . 68 The Nobel Prize . 71 The Laureate at Work . 73 References . 74 6. Out, Damned Spot! Early Forensic Applications of ABO . 77 What Blood Can Tell . 78 Is It Blood? . 78 Is It Human Blood? . 79 Whose Blood Is It? . 81 References . 85 7. Who’s Your Daddy? ABO and Paternity Testing . 87 Establishing Paternity . 87 Paternity Testing and the Courts: Europe . 89 Paternity Testing and the Courts: Britain . 91 Paternity Testing and the Courts: United States . 92 Lights! Camera! Action! . .. -
Albumin Stewardship for Fluid Replacement in Plasmapheresis Kamarena Sankar, Pharm.D
Albumin stewardship for fluid replacement in plasmapheresis Kamarena Sankar, Pharm.D. PGY-1 Resident Pharmacist Holmes Regional Medical Center Disclosure Statement .These individuals have nothing to disclose concerning possible financial or personal relationships with commercial entities (or their competitors) that may be referenced in this presentation: .Kamarena Sankar, Pharm.D. .Jay Pauly, Pharm.D. .Michael Sanchez, Pharm.D. Presentation Objective .Understand the post-implementation safety and cost data of an Albumin Stewardship Initiative for fluid replacement in plasmapheresis Background .Definition: Plasmapheresis is removal of a patient’s own plasma .Varies between patients .This also removes potentially harmful substances: .Immunoglobulin .Autoantibodies .Immune complexes .Monoclonal paraproteins .Protein-bound toxins Hollie M. Reeves Br J Haematol. 2014;164.3:342-351. Indications Guillain-Barré Syndrome, ANCA glomerulonephritis, Myasthenia Gravis, Autoimmune Encephalitis, Renal First-Line Transplantation, Thrombotic Thrombocytopenic Purpura (TTP) Cryoglobinemia, Familial Hypercholesterolemia, Second-Line Multiple Sclerosis Role Not Heparin-induced Thrombocytopenia (HIT), Nephrogenic Established Systemic Fibrosis Ineffective or Psoriasis, Dermatomyositis/Polymyositis Harmful J Schwartz. J Clin Apher. 2016;31.3:149-338. Background .Fluid Replacement during plasmapheresis: .Necessary to avoid hypotension .Institution practice: .Albumin 5% 3,000 mL .IV room processing time .Multiple manipulations .High cost J Schwartz. J Clin Apher. 2016;31.3:149-338. Background Literature .Yamada (2017) .Albumin in combination with normal saline .5:1, 4:1, 5:2, 1:1 .3 patients, 12 procedures .No blood pressure differences .Albumin only fluid replacement .Albumin-normal saline combination replacement .McCullough (1982) .Options for fluid replacement .Normal saline .Albumin Chisa Yamada. J Clin Apher. 2017;32.1:5-11. J McCullough. Vox Sang. -
6 Alternatives to Allogeneic Blood Transfusions
Best Practice & Research Clinical Anaesthesiology Vol. 21, No. 2, pp. 221–239, 2007 doi:10.1016/j.bpa.2007.02.004 available online at http://www.sciencedirect.com 6 Alternatives to allogeneic blood transfusions Andreas Pape* Dr. med. Clinic of Anaesthesiology, Intensive Care Medicine and Pain Management, J. W. Goethe University Hospital Frankfurt am Main, Theodor Stern Kai 7, 60590 Frankfurt am Main, Germany Oliver Habler Professor Dr. med. Department Head Clinic of Anaesthesiology, Surgical Intensive Care Medicine and Pain Management, Nordwest-Krankenhaus, Steinbacher Hohl 2-26, 60488 Frankfurt am Main Germany Inherent risks and increasing costs of allogeneic transfusions underline the socioeconomic rel- evance of safe and effective alternatives to banked blood. The safety limits of a restrictive trans- fusion policy are given by a patient’s individual tolerance of acute normovolaemic anaemia. Iatrogenic attempts to increase tolerance of anaemia are helpful in avoiding premature blood transfusions while at the same time maintaining adequate tissue oxygenation. Autologous trans- fusion techniques include preoperative autologous blood donation (PAD), acute normovolaemic haemodilution (ANH), and intraoperative cell salvage (ICS). The efficacy of PAD and ANH can be augmented by supplemental iron and/or erythropoietin. PAD is only cost-effective when based on a meticulous donation/transfusion plan calculated for the individual patient, and still carries the risk of mistransfusion (clerical error). In contrast, ANH has almost no risks and is more cost-effective. A significant reduction in allogeneic blood transfusions can also be achieved by ICS. Currently, some controversy regarding contraindications of ICS needs to be resolved. Artificial oxygen carriers based on perfluorocarbon (PFC) or haemoglobin (haemoglobin-based oxygen carriers, HBOCs) are attractive alternatives to allogeneic red blood cells.